Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Calcium Folinate 10 mg/ml Solution for Injection or Infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, yellowish solution, practically free from turbidity and foreign matter with pH of 7.0-8.6 and osmolarity of 275 mOsm. |
Each ml of solution for injection/infusion contains 10 mg of folinic acid provided as calcium folinate hydrate.
Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.3 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Calcium folinate |
Calcium folinate is an active metabolite of folinic acid and essential coenzyme for nucleic acid synthesis in cytotoxic therapy. Calcium folinate is frequently used to diminish the toxicity and counteract the action of folate antagonists, such as methotrexate. |
| List of Excipients |
|---|
|
Sodium chloride |
The solution for injection/infusion is packed in amber glass type I vials with grey bromobutyl rubber stopper and sealed with aluminum flip-off seals.
Available pack sizes:
1, 5, 10 vial with 3 ml
1, 5, 10 vial with 5 ml
1 vial with 10 ml
1 vial with 20 ml
1 vial with 35 ml
1 vial with 50 ml
1 vial with 100 ml
Not all pack sizes may be marketed.
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
PL 04416/1462
Date of first authorisation: 30 November 2011
Date of last renewal: 22 October 2021
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